Global Regulatory Submission Publisher
QLS are recruiting for a Global Regulatory Submission Publisher to join a project with a Global Pharmaceutical Company based in Basel on a contract basis for 12 months.
Remote working: Hybrid or fully remote (needs to be based in Switzerland)
Role objectives: Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool) and dispatch activities related to regulatory submissions (i.e., INDs, BLAs/NDAs, MAAs, HA A to Qs, Global Labeling, AnnualReports, etc.).
Key Responsibilities:
- Produce high quality, HA compliant submission outputs in varying formats (eCTD, NeeS and Paper) in adherence to assigned timelines and in compliance with worldwide HA requirements US, EU, LACan, MOW).
- Partners with Operations Submission Managers and a publishing team located in 3 regions (US, EU and India) and actively functions in a global capacity.
- Liaises /collaborates with cross functional team members and document authors (Project Management, Clinical, Nonclinical, CMC, Safety and Quality functions) to achieve timely dispatch of high-quality submissions.
- Comply with and actively apply internal work practices and guidelines.
- Support implementation of new technologies, tools and processes as well as contribute to ongoing initiatives and training efforts.
- Identify process or technical issues and propose solutions relating to timing, quality, compliance and resources.
- Contributes to process efficiencies, process documentation and knowledge transfer efforts within the RA team.
- Ensuring a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
- Ensuring compliance to the requirements from regulatory agencies.
- Maintaining the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentationformatting, standards, policies, and operating procedure requirements.
Qualification:
- BS in life sciences or a relevant discipline with min 5 years of professional work experience.
- 5-8 years submission publishing experience in Pharma orrelated industry
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Effective interpersonal skills, strong written and oral communication and presentation skills.• Project management and time management skills to manage multiple ongoing projects simultaneously.
- Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- Working knowledge ofregulatory affairs.
- Works independently and with minimal supervision.
- Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly. Analytical skills and problem solving skills.
- Ability to coordinate and work effectively with cross-functional teams
- Languages: Fluent in English (Strong oral and written skills required). Additional language is an asset.
Apply: For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 54775 in all correspondence.
